ASTM F67 - 13 (2017)

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Designation: F67 −13 (Reapproved 2017)
Standard Speciﬁcation for
Unalloyed Titanium, for Surgical Implant Applications (UNS
R50250, UNS R50400, UNS R50550, UNS R50700)
1
This standard is issued under the ﬁxed designation F67; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This speciﬁcation covers the chemical, mechanical, and
metallurgical requirements for four grades of unalloyed tita-
nium strip, sheet, plate, bar, billet, forging, and wire used for
the manufacture of surgical implants.
1.2 The values stated in either SI units or inch-pound units
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance
with the standard.
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
2
B265 Speciﬁcation for Titanium and Titanium Alloy Strip,
Sheet, and Plate
B348 Speciﬁcation for Titanium and Titanium Alloy Bars
and Billets
B381 Speciﬁcation for Titanium and Titanium Alloy Forg-
ings
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
E29 Practice for Using Signiﬁcant Digits in Test Data to
Determine Conformance with Speciﬁcations
E290 Test Methods for Bend Testing of Material for Ductil-
ity
E1409 Test Method for Determination of Oxygen and Nitro-
gen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refrac-
tory and Reactive Metals and Their Alloys by Combustion
Analysis
E2371 Test Method for Analysis of Titanium and Titanium
Alloys by Direct Current Plasma and Inductively Coupled
Plasma Atomic Emission Spectrometry (Performance-
Based Test Methodology)
E2626 Guide for Spectrometric Analysis of Reactive and
Refractory Metals
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Insertion into Bone
IEEE/ASTM SI 10 American National Standard for Metric
Practice
2.2 Aerospace Material Speciﬁcation:
3
AMS 2249 Chemical Check Analysis Limits, Titanium and
Titanium Alloys
AMS 2380 Approval and Control of Premium Quality Tita-
nium Alloys
AMS 2631 Ultrasonic Inspection Titanium Alloy Bar, Billet
and Plate
2.3 ISO Standards:
ISO 5832-2 Implants for Surgery—Metallic Materials—
Unalloyed Titanium
4
ISO 6892 Metallic Materials—Tensile Testing at Ambient
Temperature
4
ISO 9001 Quality Management Systems
4
3. Terminology
3.1 Deﬁnitions of Terms Speciﬁc to This Standard:
3.1.1 lot, n—the total number of mill products produced
from the same melt heat under the same conditions at essen-
tially the same time.
1
This speciﬁcation is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved March 1, 2017. Published April 2017. Originally
approved in 1966. Last previous edition approved in 2013 as F67 – 13. DOI:
10.1520/F0067-13R17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Dr., Warrendale, PA 15096-0001.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
 

3.1.2 cold work, n—any mechanical deformation process

performed below the recrystallization temperature which re-

sults in strain hardening of the material.

3.1.3 hot work, n—any mechanical deformation process

performed above the recrystallization temperature.

3.1.4 alpha case, n—oxygen, nitrogen or carbon-enriched,

alpha-stabilized surface which results from elevated tempera-

ture exposure.

4. Product Classiﬁcation

4.1 Product classiﬁcations are consistent with Speciﬁcations

B265,B348, and B381.

4.1.1 Strip—Any product 0.188 in. (4.76 mm) and under in

thickness and less than 24 in. (610 mm) wide.

4.1.2 Sheet—Any product 0.188 in. (4.76 mm) and under in

thickness and 24 in. (610 mm) or more in width.

4.1.3 Plate—Any product 0.188 in. (4.76 mm) thick and

over and 10 in. (254 mm) wide and over, with widths greater

than ﬁve times thickness. Plate up to 4 in. (102 mm), thick

inclusive is covered by this speciﬁcation.

4.1.4 Bar—Rounds, ﬂats, or other shapes from 0.188 in.

(4.76 mm) to 4 in. (102 mm) in diameter or thickness. (Other

sizes and shapes by special order.)

4.1.5 Forging bar—Bar as described in 4.1.4 used in the

production of forgings. This product may be furnished in the

hot worked condition.

4.1.6 Billet—A solid semi-ﬁnished section hot rolled or

forged from an ingot, with a cross sectional area greater than 16

in.

(10 322 mm

) whose width is less than 5 times its

thickness.

4.1.7 Forging—Any product of work on metal formed to a

desired shape by impact or pressure in hammers, forging

machines, upset presses, or related forming equipment.

4.1.8 Wire—Rounds, ﬂats or other shapes less than 0.188 in.

(4.76 mm) in diameter or thickness.

4.1.9 Other—Other forms and shapes, including tubing,

may be provided by agreement between purchaser and sup-

plier.

5. Ordering Information

5.1 Inquiries and orders for material under this speciﬁcation

shall include the following information:

5.1.1 Quantity (weight or number of pieces),

5.1.2 Grade (1, 2, 3, or 4),

5.1.3 ASTM designation and date of issue,

5.1.3.1 Units to be certiﬁed – SI or inch-pound,

5.1.4 Form (sheet, strip, plate, bar, billet, forging, wire, or

other forms),

5.1.5 Condition (see 6.1),

5.1.6 Mechanical properties (if applicable, for special

conditions),

5.1.7 Finish (see 6.2),

5.1.8 Applicable dimensions and tolerances including size,

thickness, width, and length (exact, random, multiples) or

drawing number,

5.1.9 Special tests (if any), and

5.1.10 Other requirements.

6. Manufacture

6.1 Condition—Material shall be furnished in the hot-

worked, cold-worked, forged, annealed, or stress-relieved con-

dition.

6.2 Finish—The mill product may be furnished as descaled

or pickled, abrasive blasted, chemically milled, ground,

machined, peeled, polished, or as speciﬁed by the purchaser.

On billets, bars, plates, and forgings, it is permissible to

remove minor surface imperfections by spot grinding if such

grinding does not reduce the dimension below the minimum

permitted by the dimensional tolerance ordered.

7. Chemical Composition

7.1 The heat analysis shall conform to the chemical com-

position of Table 1. Ingot analysis may be used for reporting all

chemical requirements, except hydrogen. Samples for hydro-

gen shall be taken from the ﬁnished mill product. Supplier shall

not ship material with chemistry outside the requirements

speciﬁed in Table 1 for the applicable grade.

TABLE 1 Chemical Requirements

Element

Composition

, % (mass/mass)

Grade 1 Grade 2 Grade 3 Grade 4

UNS R50250 UNS R50400 UNS R50550 UNS R50700

Nitrogen, max 0.03 0.03 0.05 0.05

Carbon, max 0.08 0.08 0.08 0.08

Hydrogen, max

0.015 0.015 0.015 0.015

Iron, max 0.20 0.30 0.30 0.50

Oxygen, max 0.18 0.25 0.35 0.40

Titanium balance balance balance balance

Forgings are designated Grade F-1, F-2, F-3, or F-4 respectively. Forging compositions are as speciﬁed in Table 1.

Maximum hydrogen content for billet is 0.0100 wt%.

TABLE 2 Product Analysis Tolerances

Element

Limit or Maximum of

Speciﬁed Range %,

(mass/mass)

Tolerance Under the

Minimum or Over the

Maximum Limit

Nitrogen up to 0.05 0.02

Carbon 0.10 0.02

Hydrogen up to 0.015 0.0020

Iron up to 0.25 0.10

Iron over 0.25 0.15

Oxygen up to 0.20 0.02

Oxygen over 0.20 0.03

Refer to AMS 2249.

Under minimum limit not applicable for elements where only a maximum

percentage is indicated.

F67 − 13 (2017)

7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
residual elements. Analysis for elements not listed in Table 1 is
not required to verify compliance with this speciﬁcation.
7.2 Product Analysis—
7.2.1 Product analysis tolerances do not broaden the speci-
ﬁed heat analysis requirements but cover variations in the
measurement of chemical content between laboratories. The
product analysis tolerances shall conform to the product
tolerances in Table 2.
7.2.2 The product analysis is either for the purpose of
verifying the composition of a heat or manufacturing lot or to
determine variations in the composition within the heat.
7.2.3 Acceptance or rejection of a heat or manufacturing lot
of material may be made by the purchaser on the basis of this
product analysis. Product analyses outside the tolerance limits
allowed in Table 2 are cause for rejection of the product. A
referee analysis may be used if agreed upon by supplier and
purchaser.
7.2.4 For referee purposes, use Test Methods E2371,
E2626,E1409,E1447,E1941 or other analytical methods
agreed upon between the purchaser and supplier.
7.3 Samples for chemical analysis shall be representative of
the material being tested. The utmost care must be used in
sampling titanium for chemical analysis because of its affinity
for elements such as oxygen, nitrogen, and hydrogen. In
cutting samples for analysis, therefore, the operation should be
carried out insofar as possible in a dust-free atmosphere.
Cutting tools should be clean and sharp. Samples for analysis
should be stored in suitable containers.
8. Mechanical Requirements
8.1 The material supplied under this speciﬁcation shall
conform to the mechanical property requirements in Table 3,
Table 4 and Table 5. Grades may be ordered in the cold worked
condition to higher minimum tensile strength but a minimum
10 % elongation in 4Dor 2 in. (50 mm) must be met except for
wire. See footnotes in Table 5. Alternate properties may be
agreed upon between the purchaser and supplier.
8.2 Specimens for tension tests shall be prepared and tested
in accordance with Test Methods E8/E8M. Tensile properties
shall be determined using a strain rate of 0.003 to 0.007
in/in/min (mm/mm/min) through yield and then the crosshead
speed may be increased so as to produce fracture in approxi-
mately one additional minute. Tensile tests results for which
any specimen fractures outside the gage length shall be
considered valid, if both the elongation and reduction of area
meet the minimum requirements speciﬁed. Refer to sections
7.11.4 and 7.12.5 of Test Methods E8/E8M. If either the
elongation or reduction of area is less than the minimum
requirement, invalidate the specimen and retest. Retest one
specimen for each specimen that did not meet the minimum
requirements.
8.2.1 Bar, Forging Bar, Shapes, and Wire—Test according
to Test Methods E8/E8M. Should any test specimen not meet
the speciﬁed requirements, test two additional test pieces
representative of the same lot, in the same manner, for each
failed test specimen. The lot will be considered in compliance
only if all additional test pieces meet the speciﬁed requirements
8.2.2 Tension testing of wire shall be conducted in accor-
dance with Test Methods E8/E8M Tension testing shall be
conducted using the appropriate gauge length, shown in Table
5, for the size wire being tested. For wire sizes ≥0.0625 in.
(≥1.59 mm) (4Dgauge length) a strain rate of 0.003 to 0.007
in./in. (mm/mm)/min through the speciﬁed yield strength shall
be used and then the crosshead speed shall be increased so as
to produce fracture in approximately one additional minute.
For wire diameters less than 0.0625 in. (1.59 mm) a crosshead
speed of 0.5 to 1.0 in./min (12.7 to 25.4 mm/min) shall be used.
Once yielding has begun, the crosshead speed may be in-
creased to a maximum of 3.0 in./min (76.2 mm/min).
8.2.3 Sheet, Strip, and Plate—Test according to Test Meth-
ods E8/E8M. Tests in the transverse direction need be made
only on product from which a specimen not less than 8.0 in.
(200 mm) in length for sheet and 2.50 in. (64 mm) in length for
plate can be taken. Should any of these test specimens not meet
the speciﬁed requirements, test two additional test pieces
representative of the same lot, in the same manner, for each
failed test specimen. The lot will be considered in compliance
only if all additional test pieces meet the speciﬁed require-
ments.
8.3 For sheet and strip, perform at least one bend test
according to Test Methods E290 from each lot in both the
longitudinal and transverse directions. Tests in the transverse
direction need be made only on product from which a specimen
not less than 8.0 in. (200 mm) in length for sheet and 2.50 in.
(64 mm) in length for plate can be taken. The bend test
specimen shall withstand being bent cold through an angle of
105° without fracture on the outside of the bent portion. The
bend shall be made around a mandrel which has a diameter
equal to that shown in Table 4 for the applicable grade.
9. Units of Measure
9.1 Selection—This speciﬁcation requires that the purchaser
selects the units (SI or inch-pound) to be used for product
certiﬁcation. In the absence of a stated selection of units on the
TABLE 3 Mechanical Requirements: Annealed-Bar, Billet,
Forgings, and Other Forms
A
Grade
Tensile Strength,
min
Yield Strength,
0.2 % Offset,
min
Elongation
B
in 4D,
min, %
Reduction
of Area,
min, %
C
ksi MPa ksi MPa
1 35 240 25 170 24 30
2 50 345 40 275 20 30
3 65 450 55 380 18 30
4 80 550 70 483 15 25
A
These properties apply to forgings having a maximum cross section area not
greater than 3 in.
2
(1935 mm
2
). Mechanical properties of forgings having greater
cross sections shall be negotiated between the manufacturer and the purchaser.
B
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W)
shall be measured using a gauge length of 2 in. or 4Dor 4W. The gauge length
must be reported with the test results. The method for determining elongation of
material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.
Alternatively, a gauge length corresponding to ISO 6892 may be used when
agreed upon between supplier and purchaser. (5.65 times the square root of So,
where So is the original cross sectional area.)
C
Reduction of area not required for tubing.
F67 − 13 (2017)
3
 

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摘要：

ASTM F67 - 13 (2017) 是由美国材料与试验协会发布的关于外科植入物用未合金钛（纯钛）的标准规范。该标准主要规定了用于制造外科植入物的纯钛材料的化学组成、力学性能、加工工艺及检测要求，涵盖牌号如Gr1、Gr2、Gr3、Gr4等，并提供了材料在退火状态下的拉伸强度、延伸率等关键指标。ASTM F67是医疗器械行业中最基础的钛材标准之一，广泛应用于骨科、齿科及心血管等植入器械的原材料选择。通过严格限定杂质元素含量（如铁、氧、氮）和确保生物相容性，该标准确保了纯钛在人体内使用的安全性与

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